MAUDE Adverse Event Report: VERSAH, LLC PILOT DRILL; DENTAL PILOT DRILL - BUR

Model Number VPLT

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2017

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6) 2017, but the manufacturer was not made aware of the event until (b)(6) 2017; therefore, no device evaluation could be performed, as the customer had discarded the product.However despite no device evaluation, additional information was obtained from clinician on the device indicating that the clinician used the pilot drill 50 times and applied lateral pressure while preparing the osteotomy.Upon review of the device specifications and labeling for the pilot drill, it clearly outlines that the device is to be used between 12-20 times without applying lateral force while in use.Despite the extended use and lateral pressure applied on the device by the clinician and confirmation that there was no patient injury, the manufacturer is still submitting this report as the industry continues to file these events with fda.

Event Description

While ordering a replacement pilot drill, the clinician's office indicated that their pilot drill broke back in (b)(6) 2017.After investigating further and discussing the incident with the clinician, it was determined that the pilot drill broke during surgery after being used 50 times with lateral force being applied.The clinician indicated that he was able to retrieve the broken pilot drill without issue.There was no patient injury, and surgery was performed as intended.

• Brand Name: PILOT DRILL
• Type of Device: DENTAL PILOT DRILL - BUR
• Manufacturer (Section D): VERSAH, LLC; 2500 west argyle street; suite 300; jackson MI 49202
• Manufacturer (Section G): VERSAH, LLC; 2500 west argyle street; suite 300; jackson MI 49202
• Manufacturer Contact: rhonda allen ; 2500 west argyle street; suite 300; jackson, MI 49202 ; 8447115585
• MDR Report Key: 7126275
• MDR Text Key: 95729514
• Report Number: 3011117802-2017-00003
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: VPLT
• Device Lot Number: 20041-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1